To the editor,
Re: Soller RW, Bayne HJ, Shaheen C. The Regulated Dietary Supplement Industry: Myths of an Unregulated Industry Dispelled. HerbalGram 2012;93:42-57.
This article is really great! I am curious, however, as to why 2004’s Federal Register notice (FR69 6787) “Final Rule on Ephedrine Alkaloids, etc” (21 CFR Part 119) was not included in Table 1 on “Key Developments of the Legal Framework.”
Losing the ability to prescribe ma huang [aka ephedra; Ephedra sinica, Ephedraceae] (even at 24mg/day Total Ephedrine Alkaloid) had a HUGE NEGATIVE regulatory impact on the traditional Chinese medicine (TCM) state-licensed practitioner community.
Does this regulatory precedent pose a problem for future regulatory restrictions on certain TCM herbs? Obviously.
The process of banning ma huang was a relatively easy regulatory reaction to a perceived urgent situation.
1. Practitioner-prescribed risk data on ma huang could have been obtained from Taiwan or Japan.
2. Banning herbs is not an acceptable regulatory solution for trained and licensed practitioners.
3. Maximum Daily Dosage of some herbs needs to be studied and allowed.
William Egloff Owner, Crane West Herb Company Sebastopol, CA
Thank you for your letter and for bringing to our attention that FDA’s final rule on ephedrine alkaloids in dietary supplements (Dietary Supplements that Present a Significant or Unreasonable Risk) was not included in Table 1 of our article. Table 1 is primarily focused on legislation, covering the major Acts of Congress relating to dietary supplements. Since certain FDA regulations were included in Table 1, however, we appreciate your view that FDA’s ephedra rulemaking should also have been included, as it represents a major regulatory development. We will consider inserting the ephedra rulemaking into Table 1 in a revised online version of the article.
We addressed the ephedra rulemaking and ban in the body of the article, under the section “The Effect of the Ephedra Controversy.” We understand your frustration relating to the absolute ban of ma huang, even by licensed complementary and alternative medicine (CAM) practitioners. A review of the practice (utilization) of ma huang by licensed CAM practitioners and the impact on patient care and outcomes of the ephedra ban was beyond the scope of the article. This is an area of continued interest, particularly among CAM practitioners.
Holly J. Bayne
Attorney and Founder, The Law Office of Bayne & Associates
R. William Soller, PhD
Executive Director, Center for Consumer Self Care Health Sciences
Clinical Professor of Pharmacy, University of California – San Francisco
To the editor,
Re: Engels G, Brinckman J. Cinnamon. HerbalGram 2012;95:1-5.
Just a note to say that I really enjoyed the article about cinnamon [Cinnamomum verum, Lauraceae] in the current HerbalGram. One additional “folk use” of it comes to me from Jason, my beekeeper, who suggested sprinkling it around the beehives to repel ants. After learning that, we tried it on the back porch this spring (where we had quite the invasion of them). Worked nicely. Sorry, no RCT [randomized controlled trial] randomly comparing cinnamon to inert brown powder is available.
Daniel E. Moerman
William E. Stirton Professor Emeritus of Anthropology
University of Michigan-Dearborn